Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
163825–163848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1981
QUICK-CHEM COLORIMETER
K811806 · JJQ
The Dow Chemical Co.
Chemistry · 20d
Cleared Jul 15, 1981
URIC ACID TEST
K811810 · KNK
Environmental Chemical Specialties
Chemistry · 20d
Cleared Jul 15, 1981
UROPAPER EIKEN AG
K811817 · JIL
Syn-Kit, Inc.
Microbiology · 19d
Cleared Jul 15, 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
K811832 · JJX
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Jul 15, 1981
BILIRUBINOMETER
K811840 · JJQ
Advanced Instruments, Inc.
Chemistry · 14d
Cleared Jul 15, 1981
ESKAFLOW TEST FOR GLUCOSE
K811849 · CFR
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Jul 15, 1981
DISPOSABLE TRACH T OXYGENATOR
K811890 · BZA
Airlife, Inc.
Anesthesiology · 14d
Cleared Jul 15, 1981
AMES TDA CARBAMAZEPINE TEST
K811952 · KLT
Miles Laboratories, Inc.
Toxicology · 8d
Cleared Jul 13, 1981
AXISONIC II
K810697 · HDR
Teknar, Inc.
Obstetrics & Gynecology · 119d
Cleared Jul 13, 1981
MILLIPORE DUAL RATE INTRAVENOUS CASSETTE
K811432 · LDR
Millipore Corp.
General Hospital · 52d
Cleared Jul 13, 1981
BACTAGARD
K811773 · FPB
Tri-Med, Inc.
General Hospital · 21d
Cleared Jul 13, 1981
ROSS-EMERSON PUMP, MODEL 55-R
K811779 · KQT
J. H. Emerson Co.
Gastroenterology & Urology · 20d
Cleared Jul 13, 1981
SEA MEDICAL PRODUCTS LO-VOL
K811847 · FPK
Sea Medical Products, Inc.
General Hospital · 12d
Cleared Jul 10, 1981
LIGHTNING DIALYZER
K810871 · DHY
Clintox Laboratories, Inc.
Immunology · 101d
Cleared Jul 10, 1981
MRI PROLACTIN RIA KIT
K810949 · CFT
Microanalytic Research, Inc.
Immunology · 94d
Cleared Jul 10, 1981
FIBRINOGEN CONTROL PLASMA
K811069 · KQJ
American Dade
Hematology · 81d
Cleared Jul 10, 1981
BUN RATE REAGENT
K811193 · CDS
Chem-Elec, Inc.
Chemistry · 71d
Cleared Jul 10, 1981
CT/T DATALINK-B7875 AA/B7875 AB
K811227 · JAK
General Electric Co.
Radiology · 67d
Cleared Jul 10, 1981
CASSETTE READER
K811253 · DSH
American Edwards Laboratories
Cardiovascular · 66d
Cleared Jul 10, 1981
PAPER CHART RECORDER
K811254 · DSF
American Edwards Laboratories
Cardiovascular · 66d
Cleared Jul 10, 1981
RAZEL MODEL C
K811272 · FRN
Razel Scientific Instruments, Inc.
General Hospital · 64d
Cleared Jul 10, 1981
SODIUM/POTASSIUM REAGENT KITS
K811310 · CEM
Chem-Elec, Inc.
Chemistry · 60d
Cleared Jul 10, 1981
INSIGHT
K811345 · GZJ
Staodynamics, Inc.
Neurology · 59d
Cleared Jul 10, 1981
PLAYTEX PROCESS MACHINERY CHANGE
K811386 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 53d